This article is provided by Shandong Quankeruida Instrument and Equipment.
Pharmaceutical tightness testingAs a commonly used testing method, the negative pressure method has important application value in the pharmaceutical industry. This article will analyze the importance of negative pressure drug tightness testing, and introduce the test methods in detail to provide reference for drug manufacturers.
1. The importance of negative pressure drug tightness test
1.Guarantee the quality of drugs: In the process of production, storage and transportation, the sealing performance of drugs is a key indicator to measure their quality. Through the negative pressure leak test, the sealing degree of the drug packaging can be effectively detected to ensure that the efficacy and safety of the drug will not be affected due to packaging leakage.
2.Improve the stability of drugs: During storage and transportation, drugs are affected by factors such as temperature, humidity, and light, which can easily lead to changes in chemical composition. The negative pressure leak test helps to evaluate the stability of pharmaceutical packaging in harsh environments, and provides a guarantee for drug storage and transportation.
3.Extend the shelf life of pharmaceutical products: Good sealing properties help to extend the shelf life of pharmaceutical products. Through the negative pressure method leak test, it can ensure that the pharmaceutical packaging maintains stable sealing performance during the shelf life and reduces the occurrence of quality problems.
4.Meet regulatory requirements: China's relevant regulations have clear requirements for the sealing performance of drugs. Through the negative pressure leak test, enterprises can ensure that the product meets the regulatory requirements and is successfully marketed.
2. Negative pressure drug tightness test method
1.Test principle: The negative pressure method tightness test is to produce a pressure difference between the inside and outside of the sample by extracting the gas in the vacuum chamber. Observe the escape of gas in the sample or the recovery of the shape of the sample after expansion and release of vacuum, and judge the sealing performance of the sample.
2.Test Procedure:
1) Prepare the sample: select a representative drug packaging as the sample to ensure that the surface of the sample is clean and free of damage.
2) Install the specimen: place the specimen on the test equipment to ensure that the specimen is in good contact with the equipment.
3) Vacuum: Turn on the vacuum pump to vacuum the vacuum chamber to produce a pressure difference between the inside and outside of the sample.
4) Observe the sample: In the process of extracting the vacuum, observe the escape of the gas in the sample or the recovery of the shape of the sample after expansion and release of vacuum.
5) Judgment results: According to the observed phenomena, evaluate the sealing performance of the sample. If there is no gas escape or the shape of the sample is well restored within the specified time, the sealing performance is considered to be qualified.
3.Test frequency: According to the storage and transportation conditions of the drug, as well as the product quality requirements, the negative pressure method tightness test is carried out regularly to ensure that the sealing performance of the drug packaging is always stable.
Summary
Negative pressure drug tightness test is an important means to ensure the quality of drugs, and the quality and safety of drugs in the process of production, storage and transportation can be ensured through the evaluation of the sealing performance of drug packaging. Mastering the method of negative pressure drug tightness testing will help enterprises improve product quality, meet regulatory requirements, and provide patients with safe and effective solutions.